{"title":"Opportunistic testing: the death of informed consent?","authors":"Dena S Davis","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This Article focuses on one aspect of prenatal diagnosis: noninvasive prenatal diagnosis, particularly the detection of Trisomy 21 (Down Syndrome) through a simple test of maternal blood. Although I discuss issues salient to this particular test, I place it in the context of \"opportunistic\" testing generally. It is my view that opportunistic testing presents the most serious challenge to patient autonomy we are facing in the twenty-first century. In this Article, I will explain what I mean by opportunistic testing and consider three different examples of how it threatens informed consent: (1) Prostate-Specific Antigen (PSA) screening, (2) newborn screening, and (3) prenatal diagnosis of maternal blood tests for fetal anomalies.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"23 1","pages":"35-54"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31632095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Medicine and law as model professions: the heart of the matter (and how we have missed it).","authors":"Rob Atkinson","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This article has two coordinate goals: to undergird the functionalist understanding of professionalism with classical normative theory and to advance the classical theory of civic virtue with the insights of modern social science. More specifically, this article seeks to connect classical theories about the care of the body and the soul with modern theories of market and government failure. The first step is to distinguish two kinds of professions, caring professions like medicine and public professions like law, by identifying the distinctive virtue of each. The distinctive virtue of the caring professions is single-minded commitment to those in their care, their principals, to the virtual exclusion of all other concerns; the distinctive virtue of the public professions is commitment to the common good, sometimes even at the expense of their principals' self-defined interest. The next step is to show how these two distinctive professional virtues, the one principal-protecting, the other public-protecting, branch from the same root, the common function of all proper professions: guaranteeing the delivery of socially essential but necessarily esoteric knowledge when the usual protections of both private contracts and government regulation systematically fail. The third and final step is to map out the implications of this neo-classical understanding of professionalism, beginning at its core in the paradigmatic caring and public professions of medicine and law, through putative professions that take these as their models, to the kind of republican society that places care of individuals and concern for the public welfare at the center of its value system. The result of this analysis should be not only a fuller theoretical appreciation of professionalism's proper function, but also a practical guide to professionals themselves for better service to both the individuals in their care and the common good of all humankind.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 2","pages":"345-422"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31424988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Defining intellectual disability and establishing a standard of proof: suggestions for a national model standard.","authors":"Natalie Cheung","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"23 1","pages":"317-51"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31540104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Protection for psychotherapy notes under the HIPAA Privacy Rule: as private as a hospital gown.","authors":"Stephanie O Corley","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 2","pages":"489-534"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31425969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Direct and enhanced disclosure of researcher financial conflicts of interest: the role of trust.","authors":"Roy G Spece","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In earlier writing, I recommended direct disclosure of major researcher financial conflicts of interest in per capita funding arrangements--the practice of providing researchers with a fixed sum for each subject recruited and enrolled in a study. This Article adds a recommendation for enhanced direct disclosure. The enhancement in the disclosure is a summary of why per capita and excess payments are being discussed and further includes whether the sponsors of the research and the researchers have claimed that there are no excess payments. The reason per capita payments are being discussed is because of the risk--with special caution when sponsors and researchers are not willing to claim that there are no excess payments--of introducing bias into researchers' decisions regarding study design, implementation, and interpretation, as well as concerning whom to enroll or keep in studies. Researchers' claims that there are no excess payments do not vitiate the risk of such payments. Nevertheless, a special admonition when sponsors and researchers do not claim the absence of excess payments would hopefully encourage them to eschew excess payments. My recommendations are required by the rights to bodily integrity and autonomy embedded in informed consent. Several arguments have been made against my recommendations, many of which relate to supposed effects on trust. My rights-based recommendations should not be rejected because of objections based on propositions that (1) are conceptually unclear because of a failure to unbundle different kinds and degrees of trust and (2) have not been empirically proven even where concepts are clarified. In some instances, the required strong empirical confirmation cannot be made because of practical or ethical restraints, including the fact that some of the necessary studies would require invasion of the right to informed consent. Finally, I suggest and partially apply an organizational method to generate empirical questions and guidance for future research in this area. Even the few hypothetical scenarios addressed demonstrate how complex--and sometimes practically or ethically impossible--the empirical studies must be to adduce proofs sufficient to overcome the imperative of informed consent.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"23 2","pages":"409-24"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31958724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Medical marijuana and the ADA: removing barriers to employment for disabled individuals.","authors":"Russell Rendall","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"315-43"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marcia M Boumil, Debbie F Freitas, Cristina F Freitas
{"title":"Waiver of the psychotherapist-patient privilege: implications for child custody litigation.","authors":"Marcia M Boumil, Debbie F Freitas, Cristina F Freitas","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The psychotherapist-patient privilege, rooted in both common and statutory law, is predicated upon the public policy goal of protecting the reasonable expectation of privacy of individuals seeking psychotherapy. The privilege is not absolute, however. State and federal courts are far from uniform in determining how and when the privilege should be waived, in whole or in part, through implication, inadvertence or the affirmative action of the parties. In the family law context, the law that has evolved around the exercise of this privilege is even more complex as the needs of children add another wrinkle to the goal of balancing the imperative of confidentiality with the need for useful information that may be provided.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"1-31"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"PGTandMe: social networking-based genetic testing and the evolving research model.","authors":"Valerie Gutmann Koch","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of \"patient-driven\" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.</p>","PeriodicalId":73212,"journal":{"name":"Health matrix (Cleveland, Ohio : 1991)","volume":"22 1","pages":"33-74"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30635809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}